(fra kommisjonsforordningen)

(1) Commission Implementing Regulation (EU) 2019/1793 lays down rules on the imposition of special conditions governing the entry into the Union of certain consignments of food and feed from certain third countries due to the risk of contamination by mycotoxins, including aflatoxins, pesticide residues, microbiological contamination, Sudan dyes, and plant toxins listed in Annex II to that Implementing Regulation. 

(2) Notifications in the Rapid Alert System for Food and Feed (‘RASFF’) established by Regulation (EC) No 178/2002, together with follow-up investigations carried out by the competent authorities of the Member States concerned, have identified the presence of cereulide toxin in infant formula. 

(3) The follow-up investigations of the information received from RASFF notifications have provided evidence that arachidonic acid oil originating in China and used in the manufacture of infant formula constitutes the source of contamination. 

(4) Cereulide is an emetic toxin produced by certain strains of Bacillus cereus. It is resistant to common heat treatments, including pasteurisation and sterilisation, and therefore may remain active in food until the moment of consumption. Infant formula is a product intended for a particularly vulnerable population group. The consumption of infant formula contaminated by cereulide toxin, potentially leads to severe illness or even infant fatality. The detection of cereulide toxin in infant formula led to precautionary recalls in many Member States and third countries. Several Member States reported cases of infants with gastrointestinal symptoms following consumption of infant formula that were later part of the recalls. Moreover, the deaths of two infants, suspected to be linked to consumption of recalled infant formula, are under judicial investigation in a Member State. 

(5) Those elements provide evidence that arachidonic acid oil imported from China is likely to constitutes a serious risk for human health. 

(6) It is therefore necessary to provide for an increased level of official controls and special conditions in relation to the importation of consignments of arachidonic acid oil from China. In particular, those consignments should be accompanied by an official certificate stating that all the results of sampling and analyses show the absence of cereulide toxin. The results of sampling and analyses should be attached to that certificate. 

(7) Therefore, arachidonic acid oil originating in China should be included in point 1 of Annex II to Implementing Regulation (EU) 2019/1793 due to the risk of contamination by cereulide toxin, with a frequency of identity and physical checks set at 50 % of consignments entering the Union. 

(8) To ensure legal certainty for the entry into the Union of consignments that have already been dispatched from the country of origin or from another third country, if that country is different from the country of origin, when this Regulation enters into force, it is appropriate to provide for a transitional period of two months for consignments of arachidonic acid oil from China, which are not accompanied by the results of sampling and analyses and an official certificate. During this transitional period, public health protection is ensured for those consignments, since that commodity is subject to identity and physical checks at a frequency of 50 % of consignments entering the Union. 

(9) Implementing Regulation (EU) 2019/1793 should therefore be amended accordingly. 

(10) To ensure food safety and to avoid the entry into the Union of unsafe arachidonic acid oil originating in China, this Regulation should enter into force as a matter of urgency. 

(11) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,